Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer
EUFORIA-1
1 other identifier
observational
112
1 country
17
Brief Summary
The purpose of this study was to evaluate the efficacy and safety of eribulin in standard clinical practice in patients with locally recurrent or metastatic advanced breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2012
Shorter than P25 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 31, 2016
CompletedFirst Posted
Study publicly available on registry
June 3, 2016
CompletedJune 3, 2016
April 1, 2016
4 months
May 31, 2016
June 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical benefit rate
From signing of informed consent up to 1 year
Secondary Outcomes (10)
Objective response rate
From signing of informed consent up to 1 year
Overall survival
From signing of informed consent up to 1 year
Progression-free survival
From signing of informed consent up to 1 year
Change from baseline in tumor markers CA15-3
Baseline and up to 1 year
Time to response from start of treatment
From signing of informed consent up to 1 year
- +5 more secondary outcomes
Study Arms (1)
Patients with locally recurrent or metastatic breast cancer
Patients received 1.4 mg/m2 eribulin, administered intravenously on day 1 and 8 of each 21 day cycle until disease progression or unmanageable toxicity, per routine clinical practice.
Eligibility Criteria
Patients with locally recurrent or metastatic advanced breast cancer who were treated with eribulin
You may qualify if:
- Patients diagnosed with locally recurrent or metastatic advanced breast cancer, previously treated with taxanes and anthracyclines, unless these were not indicated.
- Clinical and/or radiological documentation of location and extension of the disease at the time of starting treatment with eribulin. Patients with measurable diseases and those patients who only have non-measurable lesions are eligible.
- Medical history documentation including analytical control data (blood count and serum chemistry including hepatic and renal functions) carried out at least one week before starting treatment with eribulin. (Determining the CA15-3 tumor marker is not indispensable).
- Eribulin monotherapy (at least 1 dose) between April 2011 and March 2012, both inclusive.
- Availability of a medical history allowing monitoring of clinical progression of the patients during and after treatment with eribulin.
You may not qualify if:
- Diagnosis of any type of cancer in the last 5 years, except for non-melanoma skin cancer, cervical intraepithelial neoplasia or contralateral breast cancer.
- Patients having received any other anti-tumor treatment, whether conventional or experimental, during the week prior to starting treatment with eribulin. Treatment with bisphosphonate and corticoids is allowed if they are clinically indicated and started 28 days before treatment with eribulin.
- Lack of clinical status documentation after completing treatment with eribulin or, at least, after having been administered 3 initial cycles. This can arise in any of the following cases (they are not excluding):
- Patients whose Medical History does not state the reason and date for interruption of treatment with eribulin and their subsequent clinical progression.
- Patients still undergoing treatment with eribulin on March 31, 2012, for whom there is no data for at least the first 3 cycles.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Hospital Comarcal de Barbastro
Huesca, Spain
Complejo Hospitalario de Jaen
Jaén, Spain
Hospital Arnau de Vilanova
Lleida, Spain
Clínica Román
Madrid, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Madrid Norte Sanchinarro
Madrid, Spain
Hospital MD Anderson
Madrid, Spain
Hospital Quirón Madrid
Madrid, Spain
Hospital Sanitas La Moraleja
Madrid, Spain
Hospital Universitario Morales Meseguer
Murcia, Spain
Hospital de Navarra
Navarra, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Clínica Esperanza de Triana
Seville, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Virgen Macarena
Seville, Spain
Hospital Miguel Servet
Zaragoza, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2016
First Posted
June 3, 2016
Study Start
June 1, 2012
Primary Completion
October 1, 2012
Study Completion
November 1, 2012
Last Updated
June 3, 2016
Record last verified: 2016-04